Generally, an aspect of the inventive technology relates to an identification system for accurately and adequately identifying events or materials. Another aspect relates generally to new methods and apparatus relative to more efficient generation of a custody and control form. Specifically, at least one embodiment of the inventive technology focuses on an encrypted, character-based identification information item that is based on facts related to the event, substance, or object that it is intended to uniquely represent and thereby identify. At least one embodiment of the custody and control form aspect of the apparatus focuses on computerized generation of a specimen specific custody and control form through electronic population of at least a majority of the specimen specific custody and control form upon input of a certain number of characters. Yet another aspect of the inventive technology generally relates to an efficiency-enhanced process for assigning to individuals that are to undergo an off-site specialized procedure (e.g., a sample collection for drug testing by, e.g., a toxicology lab, or a sample collected for clinical testing by a clinical lab) the geographically most proximate site capable of performing this procedure. In a preferred embodiment, this novel method utilizes commercially available mapping software.
Substance abuse by employees is and has been a problem for employers for many years. It compromises employee productivity, lowers workplace morale, impairs job performance, and decreases job-site safety, among having other effects, resulting in perhaps hundreds of millions of dollars of losses for employers worldwide. Even employees who are not under the influence of a drug at work, but perhaps use only during weekends or after work, may not be as productive, alert, safe or effective employees as they would be otherwise. The desire to abate the ill-effects of drug use by certain groups of people (as but a few examples, employees, athletes, students and inmates) has been known for some time. Indeed, employers and others have responded to this problem with substance abuse testing of employees in order to abate the ill-effects of substance abuse. Such efforts have become key in assuring or at least improving compliance by individuals in a workplace or other setting with relevant substance abuse policies, laws or regulations to which the individuals, employees and/or workplace are subjected.
Generally, such compliance verification effort involves collection of a specimen (e.g., urine, blood, hair, tissue, oral fluid, as but a few examples) which, when tested properly, may indicate prior use by the individual tested of the target substance(s) (i.e., that substance, such as cocaine, e.g., whose use would violate an applicable policy, law or regulation). This collection occurs at a collection site, which, although typically a specialized facility that is physically separate from the individual's designated location (e.g., a factory, school, prison, or office, as but a few examples), may be located at the individual's designated location (onsite). Again, it should be understood that it is not only employers that might sponsor testing of individuals—indeed, any organization or entity, generally known as a sponsoring entity, might initiate testing of individuals affiliated with it for prior substance abuse or drug testing. An additional step involves analytical specimen testing in, e.g., a laboratory or, sometimes, onsite (at the collection site such as the workplace, e.g.). This testing typically involves the use of specially adapted analytical equipment; the test result may be positive or negative, or where an onsite testing kit is used, negative or non-negative. Often, but not always, in order to assure that a positive or non-negative result indicates use of a drug or substance in violation of a law, regulation or policy, a medical review officer may conduct a review or investigation (again, to assure that the use is not a legal, legitimate or approved use). Such medical review is often used in the case where a positive result is found, but where a positive result is found for a prospective new employee (before employment is commenced or any agreement to do so is met), the medical review process may be foregone and the prospective new hire simply not hired. Similarly, where a test kit is used (e.g., an on-site test kit) for a prospective new hire before a more reliable laboratory test is performed, a test kit result of non-negative may cause the sponsoring entity (the employer, e.g.) to simply forego the laboratory test and simply not hire the prospective new hire. Relevant in this regard is the Thct that one of the purposes of the medical review process is to improve or assure the integrity of the testing. Another step taken to assure the integrity of the test result and specifically to improve the likelihood that a test or testing process will withstand a legal challenge by, e.g., a tested individual whose employment has been terminated due to a positive result, is the use of a custody and control forms (also referred to as a chain of custody form).
However, the use of the custody and control form is not limited to drug testing, as a sample or specimen collection may be for clinical testing. Clinical testing includes testing and analysis of any substance collected (e.g., biopsies, tissue, blood, bodily fluids) for disease, abnormality, levels of a constituent (e.g., cholesterol); precursors to disease, or, indeed for any indication that remedial or treatment measures may be appropriate and benefit the health of the donor. Specific examples of clinical testing include testing for cancer, pap smears, testing for antibody or antigen presence, testing of blood) and, generally, testing of any bodily substance for any indication of less than optimal health.
The custody and control form plays an important role in substance use and clinical testing. It is valuable at least in that, when properly completed or adequately specimen specific, it can be evidence that the specimen (also known as a sample) was not tampered with in any manner during that period of time from collection of the sample from the donor (the tested individual) to testing of the sample. Typically, one may find indicated on a completed or adequately specimen specific custody and control form the following specimen specific custody and control form information items: an account information item (e.g., a number) for billing purposes; collection site information, including perhaps the site location and the identity of the collecting individual; the identity of the medical review officer (if applicable); the identity of the laboratory analyzing (or testing) the collected sample for indication of use of the target substance(s) by the donor; a specimen identification number (generally a required item); the donor's signature, and/or the collecting individual's signature or initials. It should be understood that an item of information can be a collection of data, facts, or characters, a set of data, facts or characters, in addition to merely one character). Often, the collection site (whether it be a specialized collection site or an on-site collection site that is located at, e.g., the employee's office) will obtain on its own the custody and control form (in addition to items or materials necessary for the actual sample collection, such as a cup for urine collection). The collection site may instead have received the custody and control form and/or the sample collection equipment from the laboratory, from the donor, or from the sponsoring entity. Regardless of how or from whom the custody and control form is obtained, conventional methods of placing specimen specific custody and control form information items onto a blank or only partially completed or partially specimen specific custody and control form involve manual, time consuming and labor intensive, manual “character-by-character” entry by the collection site and perhaps also the lab, MRO and third party administrator, including handwriting onto a paper copy, typing using a typewriter onto a paper copy, or typing using a computer keyboard into appropriate fields or spaces of an on-screen computer image. It is important to understand the these problems, although presented herein as being limited to custody and control forms, are found wherever manual, character-by-character data entry is required, including in the context of authorization forms. Regardless of the specific application in which the problem is found, there has indeed been a long-felt but unmet need to eliminate or at least reduce the extent of such entry.
Such manual character-by-character entry is time-consuming, inefficient, and prone to error. Further, when such data is entered character-by-character at the collection site (or indeed at any other site that specializes in pursuits and tasks other than such data entry), the need to effect such entry typically interrupts the task of at least one employee engaged in another pursuit. Such interruption and devotion of time and effort to such data entry compromises efficiency of that particular site (e.g., that collection site). Obviating the necessity of such “de-centralized” data entry would enhance efficiency of that particular site and of the overall system, perhaps reducing labor and material costs to testing service providers (including third party administrators that administrate and/or manage one or more aspects of the testing).
Were the data entry centralized at some point so that such task were an assigned and designated task to be performed by a trained employee who would expectedly devote blocks of uninterrupted time to accomplish such data entry, the aforementioned interruption associated with character-by-character data entry could be avoided or minimized and collection site (or other site or entity) efficiency would result. Such centralization could be further enhanced by, e.g., provision of software that enhances the efficiency of data entry.
Provision of a method(s) that avoids the need of any test related service provider (e.g., a specialized collection site, a third party administrator, an analytical testing laboratory, a medical review officer) to perform at least the majority of character-by-character data entry onto the custody and control form at that site can enable cost savings and free up time to better provide their service. Additional savings may be realized through exploiting new opportunities to rely on databases that are already in existence. Such databases include databases that have any data or information relative to specimen specific custody and control form information items (employee social security numbers, e.g.). Such reliance would preclude the need by any entities involved in providing the testing service to enter such data, thereby saving costs for those involved in the testing effort, in addition to avoiding another opportunity for errors to occur during a data entry event.
The custody and control form may have specimen specific information items added to it at any time during the testing process, whether at the client site (e.g., the employer office or workplace), or at the collection site, as but two examples. This information typically may include donor identifying information (e.g., name of the donor, and/or social security number of the donor) the collecting individual's name and/or signature and/or initials, the collection site, an analytical laboratory that may test a sample or specimen, the date of sample collection, any medical review officer that may be used in the process, the sponsoring entity, any third party administrator of any facet of the testing process, and perhaps also information relative to authenticity of the sample (e.g., for a urine test, a temperature strip reflecting the temperature indicated by the filled cup). At any time during the process (although this typically occurs shortly after the collection event), several individuals or entities may be given copies of a custody and control form that includes at least some of the specimen specific information items (often the custody and control form will be sent or shipped with the collected sample to a testing laboratory, but it may merely be made available online). Such a form may be referred to as an at least partially specimen specific custody and control form. An adequately specimen specific custody and control form indicates that that custody and control form includes at least those specific information items necessary to meet legal, policy or other requirements applicable to custody and control forms. Which items are necessary to render a custody and control form adequately specimen specific may depend not only on proper legal jurisdiction, but also at which point in the testing process the custody and control form is. For example, a custody and control form that includes certain specimen specific information items, but has no information relative to a laboratory's date of receipt and individual receiver of the specimen, may be an adequately specimen specific custody and control form at the time of collection but may not be adequately specimen specific after the time of receipt of the transported sample by a testing laboratory. For a custody and control form to be adequately specimen specific after the time of receipt of the shipped sample by a testing laboratory it may indeed need to have information relative to the date of receipt of the sample by the laboratory, the identity of the individual receiving the sample, and/or initials, signature or name of the individual receiving or testing the sample.
Additionally, the client, collection site or laboratory may create an electronic version of the at least partially specimen specific custody and control form (whether after they add additional information items to it or not) by electronically scanning it, and taking other necessary measures to render this scanned version available online. At any point in the process (including after some specific information items are character-by-character entered onto the custody and control form, and indeed, even before any of the information items are indicated in some manner on the form) it may be desired to print an electronically saved copy of the custody and control form so that specific information items can be written or typed onto the paper copy, and/or so that a tangible custody and control form can be sent along with the sample to a certain destination (e.g., a testing laboratory). Using conventional methods, unless the saved copy has all or most all of the information items indicated on it in some manner so that it is an adequately specimen specific custody and control form at that point in the testing process, the remaining information items may need to be manually, character-by-character entered in some manner onto either a paper copy of the incomplete custody and control form, or onto an electronic version of the incomplete custody and control form (typically through use of a computer keyboard and any necessary word processing software) in order to create an adequately specimen specific custody and control form. This is, of course, a time consuming process, particularly where the saved form is initially blank.
In addition to the aforementioned disadvantages of the manual character-by-character data entry of convention methods of generating an at least partially specimen specific custody and control form, when electronic scanning is used, the later printing of at least partially completed custody and control forms is, given the imperfect quality of the electronic scanning process, of lower quality than the paper custody and control form that was originally scanned. Further, the scanning process of course, requires an expensive electronic scanner and significant amounts of computer memory, not to mention the frequent occurrence of scanning errors (a “r” next to a “n” on a document is often read by a scanner as a “m”).
Further, using conventional methods, different parties involved in the testing process (e.g., the MRO, the collection site, the laboratory) perform duplicate re-entry steps in that the same data (e.g., specimen donor identification information item, time of collection, etc.) is often entered by each party at least once, and maybe each time an at least adequately specimen specific custody and control form is desired. Thus, the collection date may be entered at least three times (once by the collection site, once by the laboratory, and once by the MRO); such duplicative significantly compromises efficiency of the overall process, increases the opportunity for errant data entry, and generally increases costs of the process.
To further assure the integrity of the testing process (whether needed for the custody and control form to be adequately specimen specific or not), a tangible custody and control form (e.g., paper) may incorporate a signable, flexible, transferable unopened sample container assurance element, such as an adhesive paper strip, that is removable from the custody and control form and transferable around the seal formed by a closure apparatus (e.g., a lid) of the container holding the collected sample. Typically, that signable, flexible, transferable unopened sample container assurance element (which has indicated on it a specimen identification information item), would first be attached by the collector and through adherence to a closed container that contains the collected sample. It would then be signed by the donor. Ideally, the application of the signable, flexible, transferable unopened sample container assurance element would occur as soon as possible after the installation of the sample into a container and the immediately subsequent closure of that container. Signing of the signable, flexible, transferable unopened sample container assurance element would ideally occur immediately after its application to the container seal, and within sight of the donor, thereby enhancing or assuring sample authenticity. Opening of the sealed sample vial or container would typically occur at an analytical testing laboratory immediately before testing of the sample.
Often, a third party administrator will be engaged by the sponsoring entity (e.g., an employer), the collection site (if different from the employer), the analytical testing laboratory, and/or the medical review officer(s) to manage the administrative aspects of any aspect of the testing. Aspects of the testing that may be managed by the third party administrator include specifics relative to specimen collection, specimen analytical testing, and medical review, payment collection and distribution, quoting, and event scheduling (such as sample collection scheduling) or coordinating, perhaps among others.
Another problem inhering in conventional drug and clinical testing administrative processes is loss, whether through administrative, handling or other type of error, of crucial data (as but two examples, the specimen identification number, and the testing result), forms (such as the at least partially specimen specific custody and control form), or materials (such as the collected sample). What might contribute to or compound the problem is lack of recognition of the problem in a timely fashion, causing delay in the testing process, finger-pointing as to who is responsible, losses in time and effort by the testing entities, any third party administrator, the employer and the employee, a need to re-perform some or all of the testing processes, and a general negative reflection on the competence of the testing entities and any third party administrator that may exist. At times, using a conventional drug or clinical testing system, lack of timely recognition of any errors that seem to inevitably occur in the testing process exacerbates the problem caused by the error itself. Such lack of timely recognition is in greatest part attributable to the absence of any means for either prompting or informing parties involved in the drug or clinical testing process that an event that requires action on someone's part (even if that action is merely receiving a collected sample, e.g.) has occurred, or merely providing to those parties access to information relative to the occurrence of a first event, this first event a necessary prelude to a second event.
Yet another area for improvement in the conventional manner of testing (for use of controlled substances, and clinical testing) relates to how specimens are identified and tracked. Conventional methods use specimen identification numbers that, other than perhaps being numerically correlated in some manner with an immediately preceding sample collection or test assignment, for example, are entirely arbitrary in that they are not based on facts related to the specimen collection (e.g., facts relative to the time of collection and the person from whom the sample is collected). For these reasons, they may also be said to be factually disconnected from specifics of the collected sample. As such, they constitute an additional piece of data, require an additional database, and require capability (through software, perhaps), to accurately correlate this arbitrary, factually disconnected sample identification number with a donor name and sample collection time so that upon input of the arbitrary, factually disconnected sample identification number, information sufficient to adequately identify the sample or specimen (information relative to, e.g., the donor's identity and the time of collection of the sample) is revealed to an inquiring individual. Thus, their use introduces an additional opportunity for error into the system, in addition to requiring additional labor and computer equipment relative to retrieving data necessary to adequately specify or identify the specimen.
A system or method that eliminates the need for any of the aforementioned requirements attendant use of conventional specimen identification numbers would save cost in computer equipment and labor, with the ancillary benefit of reducing the risk of error in the system. Further, given that there are currently no measures to assure that different entities that assign specimen or sample identification numbers (as but two examples, different testing laboratories or different collection sites) are using the same sample identification number for a different sample (whether that sample be from a different person or given at a different time by the same person), the current system is not without risk of some error stemming from the use of the same sample identification number for a different sample.
A further disadvantage attendant conventional methods is observed during any facet of service administration or management (each of which included fee or cost quoting for, e.g., drug or clinical testing of a company's employees) that involves the determination of whether a sufficient number of a necessary facility (e.g., specialized sample collection sites) are proximate a certain area. Indeed, a client such as a company that desires to engage a third party administrator to administer drug or clinical testing of affiliated individuals (e.g., employees) may be located (or may have a related facility such as a branch or satellite office, or a factory, e.g., so located) in an area in which there is an insufficient number of necessary facilities to accommodate the company's needs in that area. For example, a company having its employees located at a company factory in Coeur D'Alene, Idaho might request testing services but, during a potential third party administrator's generation of a quote for testing that company's employees working at the Coeur D'Alene factory, the third party administrator might learn that in fact there are no collection sites in Couer D'Alene (or that the number of sites is insufficient to handle that factory's testing needs). Using conventional techniques, measures may be taken by the third party administrator to determine whether any sites are in a sufficiently close distance to the company's factory. These measures typically involve manual use of a table of collection site locations and a map to estimate distances and drive times. Of course, such is inefficient, interruptive and imprecise.